DEVICE: ELDON MILITARY KIT MKS 2521-25 (05713494000412)
Device Identifier (DI) Information
ELDON MILITARY KIT MKS 2521-25
614-10v08
Not in Commercial Distribution
614-10
Eldon Biologicals A/S
614-10v08
Not in Commercial Distribution
614-10
Eldon Biologicals A/S
For ABO and RhD Blood grouping.
Para ABO y RhD agrupación de la sangre.
Not for use for screening purposes prior to transfusion
No para uso en cribado antes de transfusion
Dry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45308 | ABO/Rh multiple blood grouping IVD, kit, agglutination |
A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of multiple ABO system and Rh group red blood cell antigens, using an agglutination method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSZ | System, Test, Automated Blood Grouping And Antibody |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K790282 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 5 and 37 Degrees Celsius |
Storage Environment Temperature: between 5 and 37 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ba9c79f1-b98a-40b1-9afb-aa02dba620a8
December 05, 2022
5
May 17, 2017
December 05, 2022
5
May 17, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
05713494000313
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4545931111
eldoncard@eldoncard.com
eldoncard@eldoncard.com